Malaysian Journal of Analytical Sciences Vol 17 No 3 (2013): 387 – 393

 

 

 

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF CLOPIDOGREL BISULPHATE

 

(Pembangunan dan Penentusahkan Kaedah RP-HPLC Terhadap Klopidogrel Bisulfat)

 

Bhagat Dimple*, Mannur Vinodh, Mastiholimath Vinayak

 

Department of Quality Assurance,

K.L.E .University’s College of Pharmacy, JNMC Campus,

 Nehrunagar, Belgaum 590 010, Karnataka, India

 

*Corresponding author: sukubhagat@gmail.com

 

 

Abstract

A novel, simple, precise, accurate and economical method has been developed and validated for the estimation of Clopidogrel bisulphate. Chromatographic analysis was performed on Hypersil BDS C₁₈ (250 × 4.6 mm, 5 µm) column. Mobile phase used was potassium dihydrogen orthophosphate buffer: acetonitrile in a ratio of 32:68, pH was adjusted to 4.0 using orthophosphoric acid and 0.1 ml of triethyl amine was added for peak sharpness. Isocratic analysis was performed on SPD-20A double beam UV spectrophotometer at a detection range of 220 nm with a flow rate of 1.0 ml/min. The retention time for clopidogrel bisulphate was 3.847 min. The linear response was found to be in a concentration range of 50-150 µg/ml with a correlation coefficient of 0.999. The mean recovery was found to be 100.67 %. Intraday and Interday precision variations were found to be 1.88 and 0.863 respectively, which are within the limit of % RSD not more than 2. Hence the developed method is simple, fast, accurate and reproducible. It is suitable for routine quality control analysis of clopidogrel bisulphate.

 

Keywords:  RP-HPLC, validation, clopidogrel bisulphate, linearity, accuracy, precision

 

References

1.       Clopidogel Drug Description on www.rxlist.com/plavix-drug.htm.

2.       Clopidogrel Information on en.wikipedia.org/ wiki/ Clopidogrel.

3.       Saddet, D., & Erkem, A. (2009). Rapid and accurate determination of clopidogrel in tablets by using spectrophotometric and chromatographic techniques. Commun Fac Sci Univ Ank Series B, 55 (1) : 1-16.

4.       Venkanna, B., Shreedhara, C., & Ajitha, M. (2011). Rapid and rugged bio analytical method development and validation clopidogrel in human plasma using liquid chromatography/ tandem mass spectroscopy, American Journal Pharmtech Research, 1 (2) : 66 - 80.

5.       Sahu, S., & Sarangi, S. Development and validation method for the estimation of clopidogrel in bulk and pharmaceutical dosage form, International Journal Research of Pharmaceutical Science, 3 (2) : 224-27.

6.       Josh, K., & Jayasehar, P. (2013). Stability indicating HPLC determination of clopidogrel bisulfate in pharmaceutical dosage forms, International Journal of Comprehensive Pharmacy, 1 (06): 1 - 5.

7.       Himani, A., Kaul, N., Paradkar, A.R., Mahadik, K.R. (2003). Stability indicating HPTLC determination of clopidogrel bisulphate as bulk drug and in pharmaceutical dosage form, Talanta 61: 581-89.

8.       Sinha, P.K., & Mrinalini, C. (2009). A Validated Stability Indicating HPTLC Method for Determination of Aspirin and Clopidogrel Bisulphate in Combined Dosage Form, Eurasian J Anal Chem, 4 (2) : 152-60.

9.       SABER, L.A., Elmosallamy, M.A. (2008). Journal of Food and Drug Analysis, Liquid Chromatographic and Potentiometric Methods for Determinations of Clopidogrel, 16 (2): 11-18.

10.    Validation of Analytical Procedures: Methodology, ICH Harmonised Tripartite Guidelines, (1996), 1-11.

11.    Validation of Analytical Procedures: Methodology, ICH Harmonised Tripartite Guidelines, (1994), 1-7.